Panlor-SS

In the U.S.

• Panlor-DC
• Panlor-SS
• Trezix
• Zerlor

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Methylxanthine

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizures medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not stop taking it without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children. '

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain or tenderness
• bleeding gums
• blood in the urine or stools
• bloody, black, or tarry stools
• chest pain
• chills
• clay colored stools
• cough
• dark urine
• decreased appetite
• dizziness
• drowsiness
• fever
• headache
• high fever
• itching or skin rash
• lightheadedness
• loss of appetite
• nausea and vomiting
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen glands
• unexplained or unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

• Agitation
• coma
• confusion
• decreased urine output
• difficulty with swallowing
• fast heartbeat
• hives
• hostility
• irritability
• lethargy
• muscle twitching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seeing, hearing, or feeling things that are not there
• seizures
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest

• Cold sweats
• darkening of the skin
• decrease in the frequency of urination
• decrease in the urine volume
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• fainting
• irregular, fast or slow, or shallow breathing
• overactive reflexes
• pale or blue lips, fingernails, or skin
• poor coordination
• shivering
• talking or acting with excitement you cannot control
• trembling or shaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• drowsiness
• relaxed and calm
• sleepiness

• Constricted, pinpoint, or small pupils (black part of the eye)
• diarrhea
• dry mouth
• gas in the stomach
• heartburn
• seeing, hearing, or feeling things that are not there

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to acetaminophen / caffeine / dihydrocodeine: oral capsule, oral tablet

General

The most frequently expected adverse reactions based on the individual components may include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus and skin reactions.[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Hepatotoxicity[Ref]

Respiratory

Dihydrocodeine:
Frequency not reported: Respiratory depression, cough suppression[Ref]

Psychiatric

Dihydrocodeine:
Frequency not reported: Confusion, physical and psychological dependence, hallucinations vivid dreams

Caffeine:
Frequency not reported: Anxiety, anxiety neurosis, excitement, insomnia, irritability, restlessness, tenseness[Ref]

Dermatologic

Dihydrocodeine:
Frequency not reported: Sweating, pruritus, skin reactions

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)

Caffeine:
Frequency not reported: Urticaria[Ref]

Hypersensitivity

Dihydrocodeine:
Frequency not reported: Anaphylactoid reactions, hypersensitivity reactions

Acetaminophen:
Rare (less than 0.1%): Anaphylactoid reactions
Frequency not reported: Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema[Ref]

Nervous system

Postmarketing reports: Serotonin syndrome

Dihydrocodeine:
Rare (less than 0.1%): Narcosis
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, headache

Caffeine:
Frequency not reported: Headaches, lightheadedness, tremor[Ref]

Renal

Dihydrocodeine:
Rare (less than 0.1%): Acute renal failure
Frequency not reported: Granulomatous interstitial nephritis

Caffeine:
Frequency not reported: Diuresis[Ref]

Cardiovascular

Dihydrocodeine:
Frequency not reported: Orthostatic hypotension

Caffeine:
Frequency not reported: Extrasystoles, palpitations, tachycardia[Ref]

Endocrine

Postmarketing reports: Adrenal insufficiency

Opioids:
Frequency not reported: Androgen deficiency[Ref]

Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis and lead to androgen deficiency; however, the causal role of opioids is unknown due to the lack of studies into the many medical, physical, lifestyle, and psychological stressors that influence gonadal hormone levels.[Ref]

Gastrointestinal

Dihydrocodeine:
Frequency not reported: Nausea, vomiting, constipation, abdominal pain, diarrhea, dry mouth, indigestion, spasm of biliary tract

Caffeine:
Frequency not reported: Diarrhea, nausea, stomach pain, vomiting[Ref]

Genitourinary

Dihydrocodeine:
Frequency not reported: Urinary retention[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, agranulocytosis[Ref]

Metabolic

Dihydrocodeine:
Frequency not reported: Anorexia[Ref]

Ocular

Dihydrocodeine:
Frequency not reported: Miosis

Caffeine:
Frequency not reported: Scintillating scotoma[Ref]

Other

Dihydrocodeine:
Frequency not reported: Fatigue

Caffeine:
Frequency not reported: Tinnitus[Ref]

Some side effects of Panlor SS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.